Sneak Peek: What the White House is Thinking About Antibiotic Resistance

The President’s Council of Advisors on Science and Technology (PCAST for short) is preparing a major report on the problem of antibiotic resistance. The report won’t be published for a few months, but today PCAST held one of its periodic meetings, and aired what it thinks the most important issues are going to be. For anyone who cares about our dwindling ability to fight infections, or the responsibilities of healthcare to curb antibiotic use, or the large role that agriculture plays in causing antibiotic resistance to emerge, its live webcast was a satisfying listen. (The webcast will be archived here but is not yet up.)

PCAST not only webcasts its meetings; it also runs live auto-transcription at the same time. Below is a partial text, which I screengrabbed as this morning’s meeting was going on, and edited for clarity and length. I found it interesting, and reassuring in the breadth of the policy issues being considered, particularly the attention paid to the role of agriculture — as well as the possibility of tech contributions to farm and hospital surveillance, and to drug innovation. It makes me very curious what the final report will say.

The main speaker was PCAST co-chair Eric Lander, PhD, president and director of the Broad Institute of MIT and Harvard, and formerly one of the principal leaders of the Human Genome Project. He said:

On how resistance is rising: “The rate of loss of antibiotics — that is to say, the development of resistance — has been increasing. Right now it’s the case that we have 2 million people who are infected with antibiotic-resistant organisms, 17 different types of antibiotic-resistant bugs recognized by the CDC as important. There are an estimated 23,000 deaths per year due to antibiotic-resistant organisms, and that doesn’t even include additional issues like deaths due to C. difficile, an organism that outgrows other bacteria when people are treated with antibiotics.”

On the lack of new drugs to combat it: “The rate of production and approval of new antibiotics has been falling rather precipitously. It went from 20 years ago, four new antibiotics being produced per year, to, over the period of 2008 to 2011, averaging less than a third of an antibiotic being produced per year.”

On not conserving the antibiotics we have: “We don’t really have great stewardship programs comprehensively in place across this country: stewardship both in the healthcare setting, and also stewardship in agriculture, where, in percent, the bulk of antibiotics are used. We’re also losing the economic incentive to develop antibiotics.”

On getting new drugs made: “To biopharmaceutical companies, it is not such a compelling proposition to develop an antibiotic for resistant bacteria, when that might be a portion of the people with bacteria, and you might succeed in treating them in two weeks — meaning, while it’s a medically wonderful thing, it might be an economically hard proposition to justify tens of billions or hundreds of millions dollars of research into if you can’t figure out how to make the money back.”

On whether technology can help: “We don’t really have the kinds of surveillance systems we would like. Technology is happily making new opportunities available to us, and there are things that can be done on the high end of technology. But we lack a lot of basic infrastructure in the health system, and we certainly lack the ability to bring in this high-end technology. And there’s always a question, when it’s a complex topic like this that cuts across so many domains, from health to agriculture to industry, are we coordinating optimally?

“There are fabulous models of antibiotic stewardship programs, programs that have best practices for diagnoses and prescription and dosing and duration and data collection — the kinds of things that will minimize the rate at which bugs will become resistant. For example, when someone comes in for a respiratory tract infection, they may want you to give them an antibiotic, but the odds are pretty good they have a viral infection and that the antibiotic is not going to do them any good and actually may cause harm; there may be harmful reactions to it. It would be very good to make sure you were treating appropriately. We’re discussing: What are the ways that we can extend, throughout the nation, best practices of antibiotic stewardship in the healthcare setting?”

On measuring agriculture’s contribution to antibiotic resistance: “We use 80% of the bulk of antibiotics on the farm. They’re used primarily for growth promotion and disease prevention, and they’re used in sub-therapeutic doses, that is to say below the dose you would treat a sick animal with — because for reasons we don’t fully understand, you get more from meat-producing animals if you treat them that way. And you may reduce general infection by treating in this kind of prophylactic way.

“You also — the data are very clear — when you’re treating continuously with low amounts of antibiotics, you produce resistance. And resistant bacteria are present in farm animals as a result. We do know that those resistant bacteria can get into humans on those farms. So there’s no doubt there’s exchange into the human population. At this point, given our reading of the literature, I don’t think we know quantitatively what, fractionally, of the overall problem it contributes to. I wish I knew. I wish I could tell you 50% is due to overuse of the medical system, 50% is due to agriculture, but we don’t know. We do know it’s not zero. We do know it’s not 100.

“We take very seriously the need to produce food on the farms. You can’t say, well, growth promotion is not an important thing. So it’s important to ask whether science can find ways to replace antibiotics with other things: probiotic mixtures of bacteria that might produce the same beneficial effects; vaccines you might give to the animals that fight off and protect against those diseases. It might be that the right combination is both to increasingly limit the use of these precious antibiotics we need for humans, while serving the needs of agriculture by developing the science and technology needed to solve these problems through other means that don’t create antibiotic resistance that could be relevant to humans.”

On how to boost new-drug innovation: “Development of new drugs involves drug discovery, drug development, drug approval and finally drug marketing. You’ve got to ask if the pipeline has declined, in fact is nearly broken, why is that and where can you intervene? What can we do to increase drug discovery, and are there roles that greater research can play at those stages in helping to identify new targets or develop the discovery of new drugs.

“Drug development means you’ve got to go run clinical trials. Clinical trials for antibiotic-resistant bacteria are tough. Do we need massive-scale clinical trials? For many purposes we should. But for urgent agents like antibiotics against drug-resistant bacteria, maybe we ought to have a different kind of a standard here, to make sure that those can get on the market, in some limited way, for the patients who most need them. And it may be that narrower clinical trials, maybe you don’t have to demonstrate what’s called non-inferiority, maybe you just have to have efficacy.

“Then there’s the hard question of economic models. If in fact it is really uneconomic to produce these drugs, or not sufficiently economic to attract in enough private innovators to do it, we may have to ask: Can you shift that model and how do you do it? Where should that money come from?”

That’s my quick re-post of just a few of the things that were said this morning. I’m intrigued to see what the report recommends when it comes out.